Somna Therapeutics has just completed a three-year push to bring its medical device from prototype to marketable product, culminating this month with the FDA clearing it for sale.
That’s got Somna’s small team in Germantown, WI, feeling good, but they’re not pausing to celebrate for long. Now, they must quickly turn their attention to the startup’s most important obstacle to date: convincing doctors and patients nationwide that Somna’s surprisingly simple product, called the Reza Band, should be considered one of the main options for fighting acid reflux that affects the throat and lungs.
Somna co-founder and CEO Nick Maris is confident they’re ready for the challenge.
“So far, we’ve been able to tiptoe through the minefield of product development and clinical trials and FDA clearance, and we’re still intact,” Maris says. “We’re kind of battle-tested to go forward.”
Somna says millions of people suffer from laryngopharyngeal reflux (LPR), a condition in which acid and other stomach contents are regurgitated back up the esophagus and into the throat and lungs. The reflux often happens while the person is sleeping, and is largely a result of a malfunctioning upper esophageal sphincter—the band of muscles at the top of the esophagus that acts as a valve, tightening and relaxing to allow food and liquids to pass through.
Smoking, obesity, aging, and injury are among the factors that can contribute to problems with that valve, Maris says. When it isn’t working properly, it can allow acid to escape the esophagus. The results can include scarring, constant coughing, problems with swallowing, a hoarse voice, sleep interruptions, and the aggravation of conditions like bronchitis and asthma. In more serious cases, it can contribute to the onset of throat cancer.
It’s worth noting that LPR is not the same as gastroesophageal reflux disease (GERD), although the two are related and the terms are sometimes used interchangeably. GERD occurs when stomach acid washes back into the esophagus, and it’s typically associated with heartburn and chest pain. Somna is marketing its device solely as a remedy for LPR.
Currently, LPR treatment options include dietary changes, wearing loose clothing, sleeping in an upright position to keep acid from backing up into the throat, taking drugs to suppress gastric acid, and surgery.
Somna is positioning the Reza Band as a first line of defense against LPR, a simple treatment that allows patients to sleep lying down. The device is a band worn around the neck that applies slight, targeted pressure—roughly as much as you might use to take someone’s pulse—just below the Adam’s apple. That pressure is enough to buttress the valve at the top of the esophagus and help it prevent stomach contents from getting through, Somna says.
“Why would a patient go with an invasive surgery or a pharmaceutical that has the potential for side effects and additional costs, when they could try this first, at the very least?” says Somna co-founder and early investor Tom Shannon.
If the device is successful, it could also help save money. Acid reflux disease costs the U.S. healthcare system billions each year, Maris says, driven in part by medications that can cost more than $2,000 per patient per year. The Reza Band, meanwhile, costs $300. Somna intends to apply next year for reimbursement by the Centers for Medicare & Medicaid Services, he says.
The device was born through a moment of frustration-turned-inspiration by Somna co-founder Reza Shaker, a gastroenterologist at the Medical College of Wisconsin (MCW). He was trying to treat a patient with a particularly vexing case of acid reflux. The reflux constantly woke her up at night, and it had damaged her vocal cords to the point that she could no longer sing in her church choir, Somna says. After several remedies failed, Shaker was stumped, and told her that “the only thing left for me to do is to put my hands around your neck and press your esophagus closed,” according to the Reza Band website.
The light bulb went off, and he stitched together the Reza Band’s crude prototype using a rubber band, gauze wrapped in tape, Velcro, and staples, Somna says. The patient went home and started seeing results right away: She slept soundly through the night while wearing the contraption, and it eventually reduced her symptoms enough that her voice recovered and she could sing in her church choir once more, Somna says.
The Reza Band is one of those ingenious ideas that are so simple that doctors unaffiliated with Somna can hardly believe no one thought of it before. Part of the reason might be that doctors treating patients with acid reflux are so focused on treating the issues inside the throat that they don’t consider seeking solutions involving the neck, Maris says. “We’re looking at trademarking ‘Think outside the throat’ as the tagline for this,” he adds.
Milwaukee-area investors Shannon and Jeff Harris joined Shaker to form Somna and were its first two investors. They recruited Maris from nearby Serigraph to run the company, which licensed the technology from MCW in 2012. Somna raised about $3.4 million from angel investors to bring the device to market, Maris says.
The first year was dedicated to evolving Shaker’s prototype into what it looks like today (see picture above). Engineers came up with new features, like a dial to adjust the band’s tightness and a magnetic clasp that
